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Background <p>Gelatin–thrombin matrix sealants (GTMS), such as Floseal and Surgiflo, are increasingly used to achieve rapid hemostasis in spine surgery, where bleeding control is challenging due to the rich epidural venous plexus. However, their comparative effectiveness and safety remain unclear. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of GTMS in spine surgery.</p> Methods <p>This systematic review and meta-analysis was performed in line with the methodological framework outlined in the PRISMA 2020 statement. A comprehensive literature search was carried out across PubMed, Embase, the Cochrane Library, and Web of Science, covering all eligible studies published up to August 2025. Randomized controlled trials evaluating the use of gelatin–thrombin matrix sealants (GTMS) versus alternative topical hemostatic agents or conventional hemostatic approaches in spine surgery were considered eligible. Pooled estimates were synthesized using a random-effects model and expressed as weighted mean differences (WMDs), standardized mean differences (SMDs), or odds ratios (ORs), together with corresponding 95% confidence intervals (CIs).</p> Results <p>Seven randomized controlled trials were included. GTMS was associated with a higher 3-min hemostasis success rate than control interventions (OR = 2.50, 95% CI: 1.40–4.45). A borderline reduction in intraoperative blood loss was observed with GTMS (SMD = − 1.05, 95% CI: − 2.11 to 0.00), and GTMS was associated with lower total postoperative drainage volume (WMD = − 16.34&#xa0;mL, 95% CI: − 24.64 to − 8.04). No significant differences were observed in intraoperative or postoperative transfusion rates, postoperative hemoglobin levels, or postoperative day 1 drainage volume. Adverse events were infrequent and comparable between groups.</p> Conclusion <p>Current randomized evidence suggests that GTMS may improve selected local hemostatic outcomes in spine surgery, particularly early hemostasis. However, the observed reduction in intraoperative blood loss was borderline and accompanied by substantial heterogeneity, and no clear benefit was observed for transfusion requirements, postoperative hemoglobin levels, or perioperative complications. The potential value of GTMS may be more relevant in procedures involving diffuse venous bleeding or technically constrained operative fields. Given the limited number of included trials and the clinical heterogeneity across surgical settings, further well-designed randomized studies are needed to clarify the patient populations and operative scenarios in which GTMS may provide clinically meaningful benefit.</p>

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Comparative safety and efficacy of gelatin–thrombin matrix sealants versus conventional hemostatic agents in spinal surgery: a systematic review and meta-analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月25日

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  • Zhiyu Fang,
  • Liulin Zhu,
  • Yuxuan Bao,
  • Zhenghua Hong,
  • Huaxing Hong

摘要

Background

Gelatin–thrombin matrix sealants (GTMS), such as Floseal and Surgiflo, are increasingly used to achieve rapid hemostasis in spine surgery, where bleeding control is challenging due to the rich epidural venous plexus. However, their comparative effectiveness and safety remain unclear. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of GTMS in spine surgery.

Methods

This systematic review and meta-analysis was performed in line with the methodological framework outlined in the PRISMA 2020 statement. A comprehensive literature search was carried out across PubMed, Embase, the Cochrane Library, and Web of Science, covering all eligible studies published up to August 2025. Randomized controlled trials evaluating the use of gelatin–thrombin matrix sealants (GTMS) versus alternative topical hemostatic agents or conventional hemostatic approaches in spine surgery were considered eligible. Pooled estimates were synthesized using a random-effects model and expressed as weighted mean differences (WMDs), standardized mean differences (SMDs), or odds ratios (ORs), together with corresponding 95% confidence intervals (CIs).

Results

Seven randomized controlled trials were included. GTMS was associated with a higher 3-min hemostasis success rate than control interventions (OR = 2.50, 95% CI: 1.40–4.45). A borderline reduction in intraoperative blood loss was observed with GTMS (SMD = − 1.05, 95% CI: − 2.11 to 0.00), and GTMS was associated with lower total postoperative drainage volume (WMD = − 16.34 mL, 95% CI: − 24.64 to − 8.04). No significant differences were observed in intraoperative or postoperative transfusion rates, postoperative hemoglobin levels, or postoperative day 1 drainage volume. Adverse events were infrequent and comparable between groups.

Conclusion

Current randomized evidence suggests that GTMS may improve selected local hemostatic outcomes in spine surgery, particularly early hemostasis. However, the observed reduction in intraoperative blood loss was borderline and accompanied by substantial heterogeneity, and no clear benefit was observed for transfusion requirements, postoperative hemoglobin levels, or perioperative complications. The potential value of GTMS may be more relevant in procedures involving diffuse venous bleeding or technically constrained operative fields. Given the limited number of included trials and the clinical heterogeneity across surgical settings, further well-designed randomized studies are needed to clarify the patient populations and operative scenarios in which GTMS may provide clinically meaningful benefit.